Drug License Brochure

Narendra Kumar

22 May, 2019

Drug License Brochure in India, you cannot start any type of pharmaceutical business without getting a valid license from authority as per law.

Drug License refers to that license which enables you to start any business dealing with drugs.

Forgetting drug license essential requirements are as follows:

Minimum required a covered area in different categories

• 10 square meter in case of Retail sale
• 10 square meter in case of wholesale
• 15 square meter in case of wholesale & Retails together

Storage Facilities

A refrigerator is required for storage and some other essential requirement like cupboards, glass doors, etc.

What are the Documents Required for Drug License (sale or wholesale)?

• A signed copy of Application Form as prescribed
• Photograph of Proprietor/Partner/Director
• Proof of payment (receipt or challan)
• A signed copy of Layout plan or blueprint of premises
• Electricity bill and Rent Agreement or Title deed for the premises
• Master documents of the Applicant like MOA/AOA or Partnership Deed
• Affidavits for non-conviction
• Details of the registered pharmacist along with educational qualification, registration certificates, and experience letter
• Details of proprietor/partners/Director who sign the application
• Proof of purchase of Deep freezer or Refrigerator/ (For Vaccines / Sera).
• Affidavit for authorized signatory if any
• Copy of Board resolution for authorization of Authorized Signatory

In case of Drug License for Manufacturing Unit following documents are required to submit an uploaded with the online application:

• A signed copy of Application Form as prescribed
• A signed copy of Layout plan or blueprint of premises
• Electricity bill and Rent Agreement or Title deed for the premises
• Master documents of the Applicant like MOA/AOA or Partnership Deed
• A complete list of current directors of the firm with their personal details
• In case of any change in directorship proof of the same is required (Form DIR-12)
• Details of the registered pharmacist along with educational qualification, registration certificates, and experience letter
• Affidavits for non-conviction of technical staff
• Proof of academic qualification and technical staff approval as per law
• List of available machinery and original bills as proof of purchase
• List of equipment’s available with lab
• Non-Objection Certificate from the fire department and pollution control department
• Proof relating to load sanction
• Allotment/occupation certificate from authority (attested copies)
• Affidavit of Directors which reflects responsibility for daily activities and conduct of the company with mentioning any conviction as per concerned law if any
• Copy of Board resolution for authorization of Authorized Signatory
• Affidavit for non-conviction of authorized signatory

What is the Procedure for getting Drug License?

Following is the procedure for Drug License–

Stage1

Firstly the Applicant has to apply and uploaded prescribed documents online to the Licensing Authority of the concerned Zone.

(Like in case of Haryana we have 10 different Zones available i.eAmbala, Karnal, Gurgaon, Sonepat, Kurukshetra, Hisar, Rothay, Faridabad, and Rewari&Sirsa)

Fees can be paid via online mode through Debit card/Credit card/Net Banking or it can also be paid via challan after downloading through the portal

Stage 2

Secondly, the application will be scrutinized and the premises will also be inspected by DCO of the Concerned District

During the inspection, DCO will verify all required facilities and documents uploaded to portal Once Inspection is done the report will be forwarded by DCO along with his recommendations to SDCO of the Concerned Zone

Stage 3

Finally, if all conditions as per law are complied with, the license will be granted by the Licensing Authority.

Note:-

• For the sale of Cosmetics, no sale license is required

Renewal of Drug License

In case of Retention of Drug License

Documents required to be submitted at the time of renewal or retention of Drug License Brochure In India, you cannot start any type of pharmaceutical business without getting a valid license from authority as per law. is as follows

• List of items which is already approved at the time of grant of License
• An undertaking which states that there is no change in the constitution
• An undertaking which states that there is no change in premises
• An undertaking which states that there is no change in premises
• An undertaking which states that there is no change technical staff
• Proof of payment of Retention fees

When Fees is deposited in full and other retention application are complied fully a validity certificate will be issued

Note:-

• Renewal fees will be equivalent to the fees which are required to get a fresh License (Inspection expenses will be excluded).
• Late fees for not paying renewal fees on or before the due date will be as follows

2% of the License fee per month/part of a month

Up to 6 months is allowed to pay renewal fees with additional fees further in case such fees are not paid, Drug License Brochure In India, you cannot start any type of pharmaceutical business without getting a valid license from authority as per law. will be deemed as canceled.

• As per notification number GSR-1337 dated 27/10/2017 Government of India has omitted the word “Renewal” and Retention is included instead of Renewal as per this Notification
• Application Forms for different applications

Form 24/24A (Application for Non-biological Drug License Brochure In India, you cannot start any type of pharmaceutical business without getting a valid license from authority as per law. manufacturing license)

Form 24B (Application for repacking of license)

Form 24C (Application for a Homeopathic manufacturing license